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OpenTrials
Completed

NCT Number: NCT00493259

Health Related QOL, Depression and Lifestyle Changes in Insulin Resistant Adolescents

The purpose of this study is to assess adolescents with Insulin Resistance Syndrome for quality of life and altered health related issues.

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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

Matched historical control study designed to examine outcomes on insulin resistant adolescents who were treated in the Insulin Resistance Syndrome Clinic at Children's Mercy Hospital in the past year. New patients will be screened at baseline, 4 and 12 months to evaluate if there is improvement in the BMI Z-score, HgA1c, lipid profile or waist circumference when depression and/or altered health related quality of life are identified and treated in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 11-17 years of age who are seen in the Insulin Resistance Clinic for the first time
  • Historical control: Patients 11-19 years of age seen in the Insulin Resistance Clinic during the prior four months

Exclusion criteria

  • Co-morbid syndrome (Downs, Turner's, Prader Willi etc)
  • Diagnosis of Type 2 Diabetes
  • Taking Metformin before the initial visit
  • Taking medication for or diagnosis of a psychiatric condition prior to initial visit
  • Developmentally delayed

Treatment and study plan

Health-Related Quality of Life instrument

Behavioral

Adolescents will fill out questionnaires regarding quality of life and dealing with diagnosis of Insulin Resistance Syndrome

Depression Scale for Children (CES-DC)

Behavioral

questionnaire

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

Health-related Quality of Life, Depression and the Impact on Successful Incorporation of Lifestyle Changes in Insulin Resistant Adolescents as Evidenced by Changes in BMI, Waist Circumference and Metabolic Parameters

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 28, 2007
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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